The FDA has granted an emergency use authorization (EUA) for the home sample collection kit made by Austin, Texas-based Everlywell Inc., which can be run on two lab-developed tests. However, the agency has also shut down a Gates Foundation-backed effort in Seattle to develop another home sample collection kit even though the organization behind the effort has been authorized by state health authorities.

The FDA announced the news about the Everlywell EUA with the stipulation that the user of the kit has completed an online questionnaire that is subsequently reviewed by a health care professional. Jeff Shuren, director of the Center for Devices and Radiological Health, said the Everlywell kit can be paired with multiple tests at multiple labs, and the home sample method thus cuts down on needless exposure. The kits, which will be paired with diagnostic tests seeking a molecular trace of viral RNA, was the beneficiary of support from the Bill and Melinda Gates Foundation, according to the FDA.

Gates also the backer of suspended testing regime

Two days earlier, the Seattle Coronavirus Assessment Network (SCAN) said it had “paused” its testing of home-based, self-collection tests that the Washington State Department of Health had authorized. The FDA’s approach to testing had included a more relaxed posture with regard to lab-developed tests when the authorities in the state had assumed responsibility for oversight, assuming the test was performed in a lab certified to handle high-complexity testing. That policy has been updated on several occasions, but retains the state authorization mechanism. Among the organizations that have backed the SCAN effort are the Bill and Melinda Gates Foundation, but Gates has himself provided funding directly for the effort.

The SCAN statement noted that the FDA had not raised any concerns about the safety or the accuracy of the organization’s test, but that the agency had requested that SCAN “pause testing” until the agency grants an EUA for the test. The group initiated the process to obtain an EUA on March 23, according to the statement, and submitted data April 13. Still, the test remains authorized by the state’s Department of Health, and SCAN said it has evaluated its tests and swabs with more than 17,000 home-collected, mid-turbinate swabs. The organization’s experience in using swabs for specimen collection spans more than 18 months, including data from the Seattle Flu study, and the data suggest a low rate of insufficient nasal sampling.

Everlywell test shipped at ambient temperatures

The EUA for the Everlywell collection kit says that the associated testing is limited to labs designated by the company, and that the nasal swab is maintained in the collection kit at ambient temperatures during transport. Everlywell’s chief medical and scientific officer, Frank Ong, told BioWorld, said the EUA is for conventional flocked swabs, adding that “we’ve secured a very large number of these swabs already,” and thus does not have any immediate plans to add 3D printed swabs to the EUA. Ong said the company currently has access to hundreds of thousands of swabs, and will not likely investigate 3D printed swabs until the inventory available to the company is running low. Any supply chain issues with conventional swabs would pique the company’s interest in swabs fabricated with the alternative manufacturing technique, however.

The kits are available to individuals and to qualifying organizations, the latter of which have had access to the specimen kids for the past eight to nine weeks, Ong said. There was no EUA needed for qualifying organizations, which are typically health care professional organizations, including front-line medical works. The list has expanded to nursing homes and state and local government health clinics, along with assisted living sites.

Ong said the EUA consumed eight weeks because of the sample transport studies requested by FDA. Several labs took part in this swab sample stability study, which demonstrated stability for at least four days, although the EUA designates this as an overnight shipping authorization. The swab kit has been studied for a temperature range of 0-40° Celsius.

The kits include swab and transport media, and Ong said the FDA requested that the company use normal saline as the transport medium. The authorization is for labs that use CDC kits and assays for the viral RNA, but Ong noted that the two labs that are listed in the EUA are only the first tranche of labs. More will be added as circumstances permit, he said.

Ong said the company’s business model has always been a self-pay model, and for this EUA, Everlywell will provide customers insurance information so the user can recover any associated expenses. Ong said the company is looking to develop a serology test for immunoglobulin G via a dried spot blood card, for which “a lot of work has already been done.”

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